Oral-healthNCT04656327
Oral Health Status in Care-dependent Community Dwelling Elders
An observational study of Oral-health and Nutritional Status, run by University of Zurich at 1 site in Switzerland.
Trial summary
The primary aim of this cross-sectional survey in Zurich is to assess the oral health status (OHS), Oral Health Related Quality of Life (OHRQoL), and the nutritional status (NS) of community-dwelling elders dependent for care. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral-health, Nutritional Status
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Sep 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly population living in the canton of Zurich, who are care-dependent and community- dwelling receiving out-patient care.
Who may be able to join
- Signed informed consent
- Living in their residence in the canton of Zurich but dependent for care for their Activities of Daily Living (ADLs)
Who cannot join
- Not willing or able to sign informed consent or not given by the caregiver/guardian.
- Age < 65 years
- Non-responsive / not cooperative for examination
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich
Zurich, 8032
Lea Angst, Med. dent., +41 795790054, lea.angst@zzm.uzh.ch
Elena van der Heijden, +41446343341, Elena.vanderHeijden@zzm.uzh.ch
About this study
Official title: Oral Health Status in Care-dependent Community Dwelling Elders: a Cross-sectional Study in Zurich
The primary aim of this cross-sectional survey in Zurich is to assess the oral health status (OHS), Oral Health Related Quality of Life (OHRQoL), and the nutritional status (NS) of community-dwelling elders dependent for care. The secondary objective of this study evaluates whether the OHS, OHRQoL and NS are influenced by cognitive status, level of dependency, socio-economic status and level of education. The tertiary objective is to assess whether the quality of nutritional uptake (refrigerator content) by the community-dwelling elders dependent for care is influenced by OHS/function, level of dependency, cognitive impairment, socio-economic status or level of education and the proximity and/or access to food sources (supermarkets).
Read the detailed description
Aim: The aim of this cross-sectional study is to assess the oral health status, Oral Health Related Quality of Life, and the nutritional status of community-dwelling elderly adults requiring care for their activities of daily living.
Methods:
Community dwelling elders residing in their homes but receiving out-patient care will be recruited in this study. Participants will receive a detailed oral examination at their residences. Their oral health status and oral function will be evaluated according to the following indices: DMF(T), plaque index (Plx), gingival index (GIx), community periodontal index for treatment needs (CPITN), xerostomia inventory (XI), brushing habits, denture calculus index (DCI), Denture Assessment (Marxkors Criteria), chewing efficiency (CE) and maximum bite force (MBF). The quality of oral care will be assessed by the use and condition of the prevalent oral hygiene tools according to the Toothbrush wear rate (TBWR). Furthermore, the Quality of Life (QoL) and Oral Health Related Quality of Life (OHRQoL) will be measured with the Oral health impact profile 14 items (OHIP-14) and EuroQol-5D (EQ-5D). Finally, the nutritional status of these care-dependent elders will be recorded with the mini nutritional assessment (MNA) as well as the recording their refrigerator content along with a 24-hour diet chart.
Discussion:
The population is ageing worldwide and teeth are being retained to an advanced age. Oral health however declines, in elders dependent for care, due to age associated complications including, multi morbidity, poly-pharmacy, cognitive and physical impairments. As a consequence, edentulous state prevails at a later age. Prevention and oral hygiene maintenance become difficult in these elders and even more complex in those who are rehabilitated with prosthetic reconstructions. Oral hygiene and care is very important in these individuals to prevent and intervene the disease process. Tooth loss combined with cognitive decline, frailty and other age-associated complications may lead to malnutrition. This study hopes to provide a reliable evaluation of the current oral health and nutritional status of elderly people living in the community and are dependent for care in an industrialised country. These data are considered cardinal and imperative for both government policies in terms of preventive programs, health educations, as well as for the organisation providing these care services.
- Conditions
- Oral-health, Nutritional Status
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this study. It is a cross-section study evaluating the oral health and nutritional statuses of community-dwelling elders dependent for care for their activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Non interventional group | Community-dwelling elders dependent for care Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Sillness and Löe Plaque index: The index measures the state of oral hygiene based on the amount of soft and mineralised debris present on the 6 indexed teeth (teeth no. 16, 12, 24, 36, 32 \& 44). The following grades will be allotted to the teeth based on the observed debris state on its four surfaces (Labial/Buccal, Mesial, Distal \& Palatal/Lingual):
0- No plaque
- A film of plaque adhering to the free gingival margin (plaque detectable only by probing)
- Moderate accumulation of plaque (plaque perceivable by naked eye and interdental space is free).
- Abundance of plaque (Interdental space is filled with plaque) x- Tooth not present. The four scores per tooth are summed and an average per tooth is calculated for that tooth. Then the mean of all the individual average scores of the examined teeth is calculated. This number gives us the plaque index for the patient.
Measured: Day 1
Gingival index
Löe and Silness Gingival Index : The index measures the degree of inflammation of the gingiva on the 6 indexed teeth (teeth no. 16, 12, 24, 36, 32 \& 44). The following grades will be allotted to the teeth based on the bleeding present after a careful probing of the gingival sulcus:
0- Normal gingiva (No inflammation, no discolouration, no bleeding, no loss of stippling)
- Low inflammation (slight color change, no bleeding)
- Moderate inflammation (redness, oedema, bleeding on probing, loss of stippling).
- Severe inflammation (redness, oedema, tendency to spontaneously bleed, ulceration, loss of stippling) x- Tooth not present The four scores per tooth are summed and an average per tooth is calculated for that tooth. Then the mean of all the individual average scores of the examined teeth is calculated. This number gives us the gingival index for the patient.
Measured: Day 1
DMF(T)
Decayed, Missing, Filled (Teeth) index: Each tooth present in the mouth will be graded as either decayed, missing or filled. Then all the numbers are added up to give us the DMF(T) status of the patient.
Measured: Day 1
CPITN index
This index measures the state of the oral health in terms of periodontal disease and the treatment needs for the patient.
All the teeth are examined and the most affected tooth per sextant is awarded a score. The following scores are possible for the teeth examined:
0- healthy (No bleeding on probing, no marginal irritation, no pockets): No treatment.
- No pockets, Bleeding on Probing, no calculus, no overhangs. Treatment: Oral hygiene instructions (OHI)
- Pockets <3mm, sub gingival calculus present, and/or iatrogenic marginal irritations (overhanging restoration margins). Treatment: OHI, scaling and correction of overhangs.
- Deepest pockets between 4 and 5 mm. Treatment: OHI, Scaling and root planing.
- Probing depth >6 mm. Treatment: Scaling \& root planing, and/or flap as required.
- - furcation is involved and/or a total loss of attachment >7mm is present. Treatment: Full periodontal examinations of all sextants regardless of CPITN score.
Measured: Day 1
Dentition Status
Assessment of status of dentition in the mouth. The examination will classify the edentulism present in the jaw as either completely edentate or partially dentate. And if Partially edentate, then the Kennedy's Classification will be applied to classify the partial edentulism present in the jaw.
We will also examine if the edentulism present is rehabilitated with what type of prosthesis ( fixed dental prosthesis/removabnle dental prosthesis/Implant supported fixed dental prosthesis or implant supported removable dental prosthesis)
Measured: Day 1
Denture Calculus index (DCI)
Denture calculus index measures the amount of soft and hard debris present on the removable dental prosthesis.
The following grades are allotted based on the presence of the debris on the prosthesis:
0- No visible plaque
- Plaque visible only by scrapping
- Moderate visible plaque
- Abundant plaque present
Measured: Day 1
Maximum bite force (MBF)
Maximum bite force is measured using a bite force meter. The patient will be requested to bite on the bite force meter first on the right side. The patient will then be requested to do the same on the left side. Three observations will be recorded for each side. The mean of the maximum bite force from both sides will be calculated and used for the analysis.
Measured: Day 1
Chewing function (CE)
Chewing function is measured using a bi-color chewing gum. The patient will chew on the chewing gums for 20 chewing cycles. The gum is flattened to a wafer thickness of 1 mm. Both sides of this wafer are scanned with a flat-bed photo scanner. The two images are brought together on a single frame using a photo software. This single image is then imported into a software (ViewGum). The software calculates the variance of hue (VoH) for each chewing gum. VoH is a numerical value and the lower the value better is the chewing efficiency.
A visual subjective assessment (SA) of the chewing gums will also be performed. The following grades will be allotted:
SA1- Chewing not mixed, only impressions of cusps are p[resent or the chewing appears folded without being mixed.
SA2- Large parts of the chewing gums are mixed. SA3- Bolus slightly mixed but bits of unmixed original color still present. SA4- Bolus well mixed, but color not uniform. SA5- Bolus perfectly mixed with uniform color.
Measured: Day 1
Oral health impact profile 14-items (OHIP-14)
OHIP-14 measures the Quality of life related to oral health. It is a subjective assessment which captures 7 dimensions (Functional limitation, Physical pain, Psychological discomfort, Physical disability, Psychological disability, Social disability and Handicap) by the means of 14- items. The participant must respond with a Likert scale-type response (4-Very often, 3-Often, 2-from time to time, 1- rarely, 0-Never). The lower the score, the better the Oral health related Quality of life (OHRQoL).
Measured: Day 1
European Quality of Life - 5 Dimensions (EQ-5D)
EQ-5D measures the general health status not specific to a disease. There are 5 dimensions (Mobility, self care, usual activities, pain/discomfort, and anxiety/depressions). There is one question per dimension and a possible Likert scale response type with three options (1- No problems, 2-Some problems, 3-Too much problems). A score between 1 and 3 is given to each of the dimensions.
Measured: Day 1
Xerostomia Inventory with 11-items (XI-11)
XI-11 assesses the xerostomia state of the participant. There are 11 questions in the inventory and the patient has the possibility to respond with a Likert-scale type response type (4-Very often, 3-Often, 2-from time to time, 1- rarely, 0-Never). The lower the score the better the index and shows the absence/reduced xerostomia.
Measured: Day 1
Mini-Nutritional Assessment (MNA)
The MNA instrument measures the nutritional state of the patient and its primary targets are under- and malnutrition states. The instrument has a two-stage structure and anamnesis with 6 items with a further 12 items including two anthropometric measurements (upper arm circumference and calf circumference). The maximum score is 30 points. The scale is:
17-23.5: risk for malnutrition <17: poor nutritional state
Measured: Day 1
Refrigerator Content
In this, we will make a record of all the items present in the participants refrigerator. All the items present will be assessed for validity of expiry and nutritional values will be calculated based on the information present on the box/label.
Measured: Day 1
Oral hygiene tools and maintenance
In this outcome, information on the frequency of the oral hygiene performed, the tools employed, condition of the oral hygiene tools present will be collected.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start26 Sep 2020
- Primary completionSep 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral-healthStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murali Srinivasan, University of Zurich
- Investigators
- Murali Srinivasan, BDS, MDS, MBA, MAS, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656327
- Sponsor's protocol ID
- UZH_ABS_2020_2
- Status last verified
- Dec 2020
- First submitted
- 17 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Status in Care-dependent Community Dwelling Elders: a Cross-sectional Study in Zurich
- ClinicalTrials.gov ID
- NCT04656327
- Acronym / sponsor ID
- UZH_ABS_2020_2
- Conditions
- Oral-health, Nutritional Status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 26 Sep 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this cross-sectional survey in Zurich is to assess the oral health status (OHS), Oral Health Related Quality of Life (OHRQoL), and the nutritional status (NS) of community-dwelling elders dependent for care. The secondary objective of this study evaluates whether the OHS, OHRQoL and NS are influenced by cognitive status, level of dependency, socio-economic status and level of education. The tertiary objective is to assess whether the quality of nutritional uptake (refrigerator content) by the community-dwelling elders dependent for care is influenced by OHS/function, level of dependency, cognitive impairment, socio-economic status or level of education and the proximity and/or access to food sources (supermarkets).
Detailed description
Aim: The aim of this cross-sectional study is to assess the oral health status, Oral Health Related Quality of Life, and the nutritional status of community-dwelling elderly adults requiring care for their activities of daily living.
Methods:
Community dwelling elders residing in their homes but receiving out-patient care will be recruited in this study. Participants will receive a detailed oral examination at their residences. Their oral health status and oral function will be evaluated according to the following indices: DMF(T), plaque index (Plx), gingival index (GIx), community periodontal index for treatment needs (CPITN), xerostomia inventory (XI), brushing habits, denture calculus index (DCI), Denture Assessment (Marxkors Criteria), chewing efficiency (CE) and maximum bite force (MBF). The quality of oral care will be assessed by the use and condition of the prevalent oral hygiene tools according to the Toothbrush wear rate (TBWR). Furthermore, the Quality of Life (QoL) and Oral Health Related Quality of Life (OHRQoL) will be measured with the Oral health impact profile 14 items (OHIP-14) and EuroQol-5D (EQ-5D). Finally, the nutritional status of these care-dependent elders will be recorded with the mini nutritional assessment (MNA) as well as the recording their refrigerator content along with a 24-hour diet chart.
Discussion:
The population is ageing worldwide and teeth are being retained to an advanced age. Oral health however declines, in elders dependent for care, due to age associated complications including, multi morbidity, poly-pharmacy, cognitive and physical impairments. As a consequence, edentulous state prevails at a later age. Prevention and oral hygiene maintenance become difficult in these elders and even more complex in those who are rehabilitated with prosthetic reconstructions. Oral hygiene and care is very important in these individuals to prevent and intervene the disease process. Tooth loss combined with cognitive decline, frailty and other age-associated complications may lead to malnutrition. This study hopes to provide a reliable evaluation of the current oral health and nutritional status of elderly people living in the community and are dependent for care in an industrialised country. These data are considered cardinal and imperative for both government policies in terms of preventive programs, health educations, as well as for the organisation providing these care services.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non interventional group | – | Other: No interventionCommunity-dwelling elders dependent for care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly population living in the canton of Zurich, who are care-dependent and community- dwelling receiving out-patient care.
Key inclusion criteria (2 listed)
- Signed informed consent
- Living in their residence in the canton of Zurich but dependent for care for their Activities of Daily Living (ADLs)
Key exclusion criteria (3 listed)
- Not willing or able to sign informed consent or not given by the caregiver/guardian.
- Age < 65 years
- Non-responsive / not cooperative for examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention in this study. It is a cross-section study evaluating the oral health and nutritional statuses of community-dwelling elders dependent for care for their activities of daily living. | Other | Non interventional group |
Primary outcome
Plaque Index
Time frame: Day 1
Sillness and Löe Plaque index: The index measures the state of oral hygiene based on the amount of soft and mineralised debris present on the 6 indexed teeth (teeth no. 16, 12, 24, 36, 32 \& 44). The following grades will be allotted to the teeth based on the observed debris state on its four surfaces (Labial/Buccal, Mesial, Distal \& Palatal/Lingual): 0- No plaque 1. A film of plaque adhering to the free gingival margin (plaque detectable only by probing) 2. Moderate accumulation of plaque (plaque perceivable by naked eye and interdental space is free). 3. Abundance of plaque (Interdental space is filled with plaque) x- Tooth not present. The four scores per tooth are summed and an average per tooth is calculated for that tooth. Then the mean of all the individual average scores of the examined teeth is calculated. This number gives us the plaque index for the patient.
Gingival index
Time frame: Day 1
Löe and Silness Gingival Index : The index measures the degree of inflammation of the gingiva on the 6 indexed teeth (teeth no. 16, 12, 24, 36, 32 \& 44). The following grades will be allotted to the teeth based on the bleeding present after a careful probing of the gingival sulcus: 0- Normal gingiva (No inflammation, no discolouration, no bleeding, no loss of stippling) 1. Low inflammation (slight color change, no bleeding) 2. Moderate inflammation (redness, oedema, bleeding on probing, loss of stippling). 3. Severe inflammation (redness, oedema, tendency to spontaneously bleed, ulceration, loss of stippling) x- Tooth not present The four scores per tooth are summed and an average per tooth is calculated for that tooth. Then the mean of all the individual average scores of the examined teeth is calculated. This number gives us the gingival index for the patient.
DMF(T)
Time frame: Day 1
Decayed, Missing, Filled (Teeth) index: Each tooth present in the mouth will be graded as either decayed, missing or filled. Then all the numbers are added up to give us the DMF(T) status of the patient.
CPITN index
Time frame: Day 1
This index measures the state of the oral health in terms of periodontal disease and the treatment needs for the patient. All the teeth are examined and the most affected tooth per sextant is awarded a score. The following scores are possible for the teeth examined: 0- healthy (No bleeding on probing, no marginal irritation, no pockets): No treatment. 1. No pockets, Bleeding on Probing, no calculus, no overhangs. Treatment: Oral hygiene instructions (OHI) 2. Pockets <3mm, sub gingival calculus present, and/or iatrogenic marginal irritations (overhanging restoration margins). Treatment: OHI, scaling and correction of overhangs. 3. Deepest pockets between 4 and 5 mm. Treatment: OHI, Scaling and root planing. 4. Probing depth >6 mm. Treatment: Scaling \& root planing, and/or flap as required. * - furcation is involved and/or a total loss of attachment >7mm is present. Treatment: Full periodontal examinations of all sextants regardless of CPITN score.
Dentition Status
Time frame: Day 1
Assessment of status of dentition in the mouth. The examination will classify the edentulism present in the jaw as either completely edentate or partially dentate. And if Partially edentate, then the Kennedy's Classification will be applied to classify the partial edentulism present in the jaw. We will also examine if the edentulism present is rehabilitated with what type of prosthesis ( fixed dental prosthesis/removabnle dental prosthesis/Implant supported fixed dental prosthesis or implant supported removable dental prosthesis)
Denture Calculus index (DCI)
Time frame: Day 1
Denture calculus index measures the amount of soft and hard debris present on the removable dental prosthesis. The following grades are allotted based on the presence of the debris on the prosthesis: 0- No visible plaque 1. Plaque visible only by scrapping 2. Moderate visible plaque 3. Abundant plaque present
Maximum bite force (MBF)
Time frame: Day 1
Maximum bite force is measured using a bite force meter. The patient will be requested to bite on the bite force meter first on the right side. The patient will then be requested to do the same on the left side. Three observations will be recorded for each side. The mean of the maximum bite force from both sides will be calculated and used for the analysis.
Chewing function (CE)
Time frame: Day 1
Chewing function is measured using a bi-color chewing gum. The patient will chew on the chewing gums for 20 chewing cycles. The gum is flattened to a wafer thickness of 1 mm. Both sides of this wafer are scanned with a flat-bed photo scanner. The two images are brought together on a single frame using a photo software. This single image is then imported into a software (ViewGum). The software calculates the variance of hue (VoH) for each chewing gum. VoH is a numerical value and the lower the value better is the chewing efficiency. A visual subjective assessment (SA) of the chewing gums will also be performed. The following grades will be allotted: SA1- Chewing not mixed, only impressions of cusps are p[resent or the chewing appears folded without being mixed. SA2- Large parts of the chewing gums are mixed. SA3- Bolus slightly mixed but bits of unmixed original color still present. SA4- Bolus well mixed, but color not uniform. SA5- Bolus perfectly mixed with uniform color.
Oral health impact profile 14-items (OHIP-14)
Time frame: Day 1
OHIP-14 measures the Quality of life related to oral health. It is a subjective assessment which captures 7 dimensions (Functional limitation, Physical pain, Psychological discomfort, Physical disability, Psychological disability, Social disability and Handicap) by the means of 14- items. The participant must respond with a Likert scale-type response (4-Very often, 3-Often, 2-from time to time, 1- rarely, 0-Never). The lower the score, the better the Oral health related Quality of life (OHRQoL).
European Quality of Life - 5 Dimensions (EQ-5D)
Time frame: Day 1
EQ-5D measures the general health status not specific to a disease. There are 5 dimensions (Mobility, self care, usual activities, pain/discomfort, and anxiety/depressions). There is one question per dimension and a possible Likert scale response type with three options (1- No problems, 2-Some problems, 3-Too much problems). A score between 1 and 3 is given to each of the dimensions.
Xerostomia Inventory with 11-items (XI-11)
Time frame: Day 1
XI-11 assesses the xerostomia state of the participant. There are 11 questions in the inventory and the patient has the possibility to respond with a Likert-scale type response type (4-Very often, 3-Often, 2-from time to time, 1- rarely, 0-Never). The lower the score the better the index and shows the absence/reduced xerostomia.
Mini-Nutritional Assessment (MNA)
Time frame: Day 1
The MNA instrument measures the nutritional state of the patient and its primary targets are under- and malnutrition states. The instrument has a two-stage structure and anamnesis with 6 items with a further 12 items including two anthropometric measurements (upper arm circumference and calf circumference). The maximum score is 30 points. The scale is: 17-23.5: risk for malnutrition <17: poor nutritional state
Refrigerator Content
Time frame: Day 1
In this, we will make a record of all the items present in the participants refrigerator. All the items present will be assessed for validity of expiry and nutritional values will be calculated based on the information present on the box/label.
Oral hygiene tools and maintenance
Time frame: Day 1
In this outcome, information on the frequency of the oral hygiene performed, the tools employed, condition of the oral hygiene tools present will be collected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murali Srinivasan, BDS, MDS, MBA, MAS principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral-health and Nutritional Status, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lea Angst, Med. dent. (+41 795790054, lea.angst@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (time frame: Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.